Regulatory Affairs Specialist Jobs in Rahway, NJ

Drive global regulatory strategies for pharmaceutical development programs, ensuring compliance and effective submissions. Lead cross-functional teams and navigate complex regulatory landscapes to ach...

Lead the charge in optimizing clinical trial operations, ensuring compliance and data integrity across multiple sites. Collaborate with investigators and cross-functional teams to enhance trial qualit...

Lead the site sterility assurance program, optimizing compliance with regulations and manufacturing best practices, while collaborating cross-functionally to protect product quality and patient safety...

Unlock potential by driving strategic revenue growth in RTSM within global CRO partnerships. As an expert, you'll support sales strategies, potential deals, and amplify Medidata's market presence thro...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Elevate clinical outcomes by serving as the key pharmacist liaison among partners, translating real-world issues into actionable insights, driving resolution of clinical concerns, and enhancing produc...

Tackle operational readiness within the expansion of a sterile drug manufacturing facility, ensuring compliance, collaboration, and efficiency. Lead equipment design, system qualification, and support...

Join a team that's shaping healthcare through innovative legal counsel. You'll oversee commercial contracting, guide compliance, and streamline legal operations for critical partnerships in health sys...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Champion regulatory compliance by overseeing GXP applications and ensuring effective validation processes within high-stakes global pharmaceutical environments while leading diverse teams with minimal...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Discover a pivotal role in establishing enterprise data stewardship standards, leading cross-domain collaboration, and ensuring consistency in planning data definitions and accountability across funct...

Grow your career with a proactive role ensuring quality standards, leading CAPA initiatives, and driving continuous improvement in a dynamic environment. Leverage your experience to impact product qua...

Shape regulatory strategies that drive product innovation and compliance, ensuring alignment with FDA and global standards. Collaborate across teams to enhance product development and market entry in...

Join a team that's dedicated to maintaining Good Clinical Practice and human subject protection. Oversee site monitoring, ensure compliance, and support clinical studies through effective communicatio...

Lead the charge in ensuring product integrity as a strategic Sr. Regulatory & Quality Systems Engineer. Own compliance across markets, manage quality systems, and drive regulatory strategy while shapi...

Unlock potential by providing strategic CMC regulatory expertise to accelerate the development and lifecycle management of drug-device combination products, ensuring compliance with global regulations...

Shape regulatory strategies for drug-device combination products, ensuring compliance with global standards while collaborating across teams to support development and lifecycle management in a hybrid...

Lead the charge in ensuring compliance for sterile and OSD manufacturing processes by managing batch reviews, documentation, and investigations, while training staff and participating in regulatory in...

Lead the charge in regulatory advertising strategies while overseeing day-to-day activities and development for assigned products. Collaborate with cross-functional teams and ensure compliance with ev...

Help us drive product success in biopharma by managing lifecycle initiatives, collaborating cross-functionally, and supporting growth strategies to enhance profitability and customer satisfaction acro...

Accelerate your career by leading negotiations for strategic contracts, aligning commercial goals with legal standards. Partner across teams to support growth, mitigate risks, and enhance customer sat...